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CoolCap Trial, Treatment of Perinatal Hypoxic-Ischemic Encephalopathy

NCT00383305 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2006-10-03

No results posted yet for this study

Summary

This is a research study of head cooling. Its goal is to determine whether cooling babies' heads can reduce or prevent brain damage that may have resulted from temporarily reduced oxygen supply to the brain. In this study, half of the babies (selected at random) will have a special cooling cap with circulating water placed on their head for 72 hours to lower the temperature of their brain. The rest of the baby's body will be maintained at a defined temperature by a standard overhead radiant heater. The study protocol includes the taking and analysis of blood samples, performance of brain wave tests, imaging of the brain by ultrasound, and other tests as clinically indicated. Neurodevelopmental outcome will also be assessed at 18 months of age.

Conditions

  • Neonatal Hypoxic-Ischemic Encephalopathy (HIE)

Interventions

DEVICE

Cool-Cap

Sponsors & Collaborators

  • Olympic Medical

    lead INDUSTRY

Principal Investigators

  • Peter D Gluckman, M.D. · The Liggins Institute, University of Auckland; Auckland, New Zealand

  • John S. Wyatt, M.D. · University College London; London, UK

  • Alistair J Gunn, M.D., Ph.D. · Department of Physiology, University of Auckland; Auckland, New Zealand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
6 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-07-31
Completion
2003-09-30

Countries

  • United States
  • Canada
  • New Zealand
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00383305 on ClinicalTrials.gov